ArticleCancers2025
Hepatic Arterial Infusion Chemotherapy with Serplulimab and the Bevacizumab Biosimilar HLX04 for Advanced Hepatocellular Carcinoma: A Prospective, Observational Phase II Clinical Trial.
Article in Cancers, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- A habitat radiomics model based on contrast-enhanced MRI for predicting early treatment response to hepatic arterial infusion chemotherapy in patients with unresectable hepatocellular carcinoma.Cellular oncology (Dordrecht, Netherlands) · 2026Article
- Article
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Authors and funding
11 authors.
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No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND/
objectivesAdvanced hepatocellular carcinoma (HCC) presents limited treatment options; however, immunotherapy demonstrates encouraging outcomes and acceptable adverse reactions in advanced HCC. This study evaluates the efficacy and safety of combining serplulimab, the bevacizumab biosimilar HLX04, and hepatic arterial infusion chemotherapy (HAIC) as a first-line therapy.
methodsThis prospective, observational, single-center phase II trial enrolled untreated HCC patients with Barcelona Clinic Liver Cancer (BCLC) stage C. All patients received serplulimab (4.5 mg/kg) and HLX04 (15.0 mg/kg) every 3 weeks, followed by the HAIC-FOLFOX regimen. The primary endpoint was the objective response rate (ORR). Secondary endpoints included the disease control rate (DCR), progression-free survival (PFS), and safety.
resultsA total of 32 patients were enrolled. The best outcomes showed an ORR of 53.1%, including 17 partial responses (PR, 53.1%) and 12 stable diseases (SD, 37.5%), resulting in a DCR of 90.6%. Subgroup analysis showed a higher ORR in patients with a single lesion and those receiving ≥3 treatment cycles, with an ORR of 60.7% in the latter group. Additionally, five patients underwent successful hepatectomy after ≥3 treatment cycles, with postoperative pathology confirming extensive tumor necrosis. Kaplan-Meier analysis estimated PFS rates of 89.9% (95% CI: 79.5-100.0%) at 6 months and 70.8% (95% CI: 54.2-92.4%) at 12 months. No deaths related to adverse events (AEs) occurred; four (12.5%) patients experienced grade IV AEs and twelve (37.5%) patients experienced grade III AEs.
conclusionsSerplulimab, HLX04, and HAIC combined as a first-line treatment for advanced HCC have demonstrated promising efficacy, particularly in patients completing ≥3 cycles, with an acceptable safety profile. Further investigation in larger trials is required.
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